A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

  • Interventional
  • Not Recruiting
  • NCT02167945
Eligibility Details Visit Clinicaltrials.gov

An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)

The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Gender
All

Age Group
18 Years to 99 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         1. Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control

         2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)

         3. HCV genotype 1 infection per screening laboratory result

        Exclusion Criteria:

         1. Use of contraindicated medications within 2 weeks of dosing

         2. Abnormal laboratory tests

         3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody

         4. Clinical history of liver decompensation

         5. Presence of hepatocellular carcinoma at screening
  • Hepatitis C

At a Glance

National Government IDNCT02167945

IRB#IRB14-0629

Lead SponsorAbbVie

Lead PhysicianHelen S. Te

Collaborator(s)N/A

EligibilityAll
18 Years to 99 Years
Not Recruiting